NIH Collaboratory Trials

June 2, 2026: Highlights From the FM-TIPS Trial: An Interview With Kathleen Sluka

Posted on by Damon Seils

FM-TIPS, an NIH Collaboratory Trial, examined whether the addition of transcutaneous electrical nerve stimulation (TENS) to routine outpatient physical therapy improves pain compared with physical therapy alone among patients with fibromyalgia. The study team recently published the main outcomes of the trial, finding that the intervention led to meaningful reductions in movement-evoked pain, resting pain, and movement-evoked fatigue.

At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with co–principal investigator Kathleen Sluka about the results of the study and lessons for future pragmatic research.

Go to the full interview.

FM-TIPS is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Learn more about FM-TIPS.

In the coming weeks, we will share more highlights from the 2026 Annual Steering Committee Meeting. Access the complete meeting materials.

Still from a video interview with Dr. Kathleen Sluka.

May 28, 2026: Study Design Paper Published for AIM-CP

Posted on by Damon Seils
Headshots of Dr. Sebastian Tong and Dr. Kushang Patel
Dr. Sebastian Tong and Dr. Kushang Patel, principal investigators for AIM-CP

The study design paper for AIM-CP has been published online in PLoS One. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The AIM-CP trial is testing the implementation of a nurse care management program, consisting of care coordination, cognitive behavioral therapy, and referral to a remotely delivered exercise program, to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The study team recently reported the results of a pilot study showing that their integrated nurse care management approach is feasible and effective.

The study is being led by Sebastian Tong and Kushang Patel of the University of Washington and is supported through the NIH HEAL Initiative by a grant from the National Institute of Nursing Research.

Read the full study design paper.

May 19, 2026: NIH Collaboratory Hosts 2026 Steering Committee Meeting; Califf and Weinfurt Share Reflections

Posted on by Damon Seils
Dr. Kevin Weinfurt and Dr. Robert Califf sit for an interview at the NIH Pragmatic Trials Collaboratory 2026 Annual Steering Committee Meeting
Dr. Kevin Weinfurt and Dr. Robert Califf

The NIH Pragmatic Trials Collaboratory held its 2026 Annual Steering Committee Meeting in Bethesda, Maryland, on April 13 and 14.

Program leaders discussed new methods and areas of focus for pragmatic trials, the value of incorporating qualitative research methods into these studies, and the importance of in-depth feasibility assessment in the planning phase. Presenters shared lessons from their new, ongoing, and completed NIH Collaboratory Trials and shared strategies for boosting the efficiency, relevance, and impact of their work.

All materials from the meeting are now available online.

The meeting began with a session moderated by former FDA Commissioner Robert Califf to consider what is on the horizon for the NIH Pragmatic Trials Collaboratory. Panelists discussed the priority evidence that can be addressed through pragmatic trials embedded in healthcare systems and the methods and knowledge required for the next generation of these studies.

Califf joined NIH Collaboratory Coordinating Center co–principal investigator Kevin Weinfurt after the session for an interview.

“When we started the [NIH Collaboratory], you could see that the technology was going to develop so that we could use electronic health records, claims data, and patient-derived data to answer a lot more questions more quickly,” Califf recalled. Califf led the research team that responded to the request for applications that prompted the formation of the NIH Pragmatic Trials Collaboratory program in 2012.

“I don’t think technology is any longer the limitation,” Califf said, “it’s really how we work together as people to make this machine work quickly to answer questions that are critical to the health of the population.”

“We’ve got a really fragmented, dynamic healthcare system,” added Weinfurt, “and alignment with leadership in those health systems to identify important questions is something we’re going to have to keep tracking and learning how to do better as that environment changes.”

See the full interview.

The NIH Pragmatic Trials Collaboratory added 2 new trials in the past year. CARNATION will test a multicomponent implementation support intervention to enable community health centers’ systematic use of electronic health record technologies for coordinating primary care–based pain care. The EquiP PC trial will test an adapted behavioral health integration toolkit to improve chronic pain care. Both projects are supported through the NIH HEAL Initiative by grants from the National Institute of Neurological Disorders and Stroke.

Learn more about the NIH Collaboratory Trials.

In the coming weeks, we will share more highlights from the 2026 Annual Steering Committee Meeting. Access the complete meeting materials.

May 12, 2026: I CAN DO Surgical ACP Validation Study Shows Acceptability of Patient Portal Messages for Preoperative Advance Care Planning

Posted on by Damon Seils
Headshots of Drs. Elizabeth Wick, Genevieve Melton-Meaux, and Rebecca Sudore
Left to right: Dr. Elizabeth Wick, Dr. Genevieve Melton-Meaux, and Dr. Rebecca Sudore, principal investigators for I CAN DO Surgical ACP

In a validation study for the I CAN DO Surgical ACP trial, researchers found that a single message delivered through the digital patient portal led to a meaningful increase in documentation of advance care planning among older patients scheduled for a new outpatient colorectal surgery clinic visit.

The article was published online ahead of print in the Joint Commission Journal on Quality and Patient Safety.

The validation study showed that incorporating the patient portal message into the preoperative workflow increased documentation of advance care planning. Moreover, patients who uploaded their documentation to the EHR opened the portal message faster than patients who did not upload documentation, suggesting that surgery is an important time point for engaging patients in advance care planning.

Read the full article.

I CAN DO Surgical ACP, an NIH Collaboratory Trial, is testing a system-based approach to helping older adults who are undergoing elective surgery to engage in advance care planning. Another goal of the study is to improve understanding of digital engagement, language, and social drivers of health that drive engagement in the intervention. The trial is supported by the National Institute on Aging.

Learn more about I CAN DO Surgical ACP.

Grand Rounds April 24, 2026: Key Insights from the UG3: Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations Trial, and Path Forward for the UH3 (Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN; Hulin Wu, PhD, MS; Jane Bolin, PhD, JD, RN)

Posted on by terren.green@duke.edu

Speakers

Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
Maria C. and Christopher J. Pappas Family Distinguished Chair in Nursing
Lee and Joseph Jamail Distinguished Professor
Department of Research
Cizik School of Nursing at UTHealth Houston

Hulin Wu, PhD, MS
The Betty Wheless Trotter Professor & Chair
Department of Biostatistics & Data Science
School of Public Health at UTHealth Houston

Jane Bolin, PhD, JD, RN
Senior Research Professor
College of Nursing, UNT Health Science Center at Fort Worth
Regents Professor Emeritus
Texas A&M School of Nursing

Keywords

Auricular Point Acupressure, Chronic pain, Pain management, Rural communities.

Key Points

  • Auricular Point Acupressure (APA) uses small seeds embedded into tape and placed on areas of the ear that correspond to areas of the body that are in pain. Placement decisions come from the literature on (APA) locations. APA has been shown to stimulate the central nervous system in fMRI studies, decreased pro-inflammatory substances (IL-ꞵ, TNFα), and increased anti-inflammatory substances (IL-4, IL-10).
  • To scale APA care, our self-managed approach for the Personalized Auricular Point Acupressure for Chronic Pain Self-management in Rural Populations UG3 study used an electronic application that was created to provide participants with tutorial videos, answers to frequently asked questions, and a pain tracking system. A previous study using this self-managed approach in urban areas showed improved physical function and lessoned pain intensity.
  • The current study focused on APA in rural communities that experience challenges with access to pain care, transportation, staff shortages, and technology and internet access. Building trust with rural communities was very important.
  • After the APA intervention, participants felt a regained control over pain and were satisfied with improved comfort. Challenges presented with difficulty reaching points on the back of the ear and discomfort while sleeping.
  • A full UH3 Pragmatic Randomized Clinical Trial is now being organized to expand the reach of the study. This 3-arm trial will randomize 693 participants to a control, APA in-person, or APA remote group. This study aims to determine the effectiveness of APA in chronic musculoskeletal pain, assess the cost-effectiveness, and identify predictive factors for APA treatment response.

Discussion Themes

Supporting rural communities in research requires leveraging existing partners while building new relationships, listening to the needs of the community and adjusting study procedures to meet these needs, and working with community advisory boards to disseminate findings.

The control group for this study was a pain education intervention group. Creating a sham control group for this type of study is difficult because there are many APA points in the ear. Attempting to create a sham control group that targets other points in the ear may inadvertently be influencing other APA points.

 

Read more about the Personalized Auricular Point Acupressure for Chronic Pain Self-management in Rural Populations study.

 

April 7, 2026: Enrollment Begins for AIM-CP and RAMP Pragmatic Trials

Posted on by Damon Seils

Two of the NIH Collaboratory Trials began enrollment last week. Congratulations to the study teams from AIM-CP and RAMP for reaching this important project milestone!

Headshots of Dr. Sebastian Tong and Dr. Kushang Patel
Sebastian Tong and Kushang Patel, principal investigators for AIM-CP

AIM-CP (Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain) is testing the implementation of a care management model to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The program includes care coordination, cognitive behavioral therapy, and referral to a virtual exercise program. The study is led by principal investigators Sebastian Tong and Kushang Patel of the University of Washington.

The AIM-CP study team recently reported the results of a pilot study showing that their integrated nurse care management model is a feasible and effective way to deliver nonpharmacological chronic pain treatment to patients in rural communities. Learn more about AIM-CP.

Headshots of Diana Burgess, Roni Evans, and Katherine Hadlandsmyth
Diana Burgess, Roni Evans, and Katherine Hadlandsmyth, principal investigators for RAMP

RAMP (Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention) is evaluating the use of a 9-week mind-body skills training program for rural veterans with pain within the VA’s Whole Health initiative, including a one-on-one session with a health coach followed by weekly group sessions that include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions. The principal investigators are Diana Burgess and Roni Evans of the University of Minnesota and Katherine Hadlandsmyth of the University of Iowa.

A recently published pilot study allowed the research team to identify several strategies to optimize the RAMP intervention for the full-scale randomized trial, including strategies to reduce participant burden and improve retention and tailor the program to the rural veteran experience. Learn more about RAMP.

Both AIM-CP and RAMP are supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by grants administered by the National Institute of Nursing Research.

April 2, 2026: In FM-TIPS Pragmatic Trial, Adding TENS to Physical Therapy Improved Fibromyalgia Pain

Posted on by Damon Seils

Headshots of Dr. Kathleen Sluka and Dr. Leslie Crofford
Dr. Kathleen Sluka and Dr. Leslie Crofford, principal investigators for FM-TIPS

Adding transcutaneous electrical nerve stimulation (TENS) to physical therapy reduced pain for patients with fibromyalgia, according to the FM-TIPS pragmatic clinical trial.

The results of the study were published online in JAMA Network Open.

FM-TIPS, an NIH Collaboratory Trial, examined whether the addition of TENS to routine outpatient physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. TENS is a noninvasive, nondrug therapy that delivers low-voltage electrical currents through electrodes placed on the skin.

The study was led by principal investigators Kathleen Sluka of the University of Iowa and Leslie Crofford of Vanderbilt University.

"TENS is a safe, effective treatment for movement-evoked pain and fatigue in individuals with fibromyalgia," Sluka said."It is an inexpensive and readily available treatment that individuals can use at home to help manage their pain," she added.

The study team randomly assigned 28 outpatient physical therapy clinics in 6 healthcare systems to provide either physical therapy plus TENS or physical therapy alone to patients enrolled in the study. Across the participating clinics, 384 patients completed baseline data collection from February 2021 through September 2024 and completed final data collection by March 2025. Patients in the TENS group were instructed to apply the electrodes to the upper and lower back and wear them for 2 hours per day with a minimum of 30 minutes per session.

FM-TIPS logoAfter 60 days, movement-evoked pain was significantly lower among patients receiving physical therapy plus TENS compared with patients receiving physical therapy alone. In an extension of the study from day 60 to day 180, patients in the physical therapy only group began receiving TENS and patients in the TENS group continued with the treatment. At 180 days, 81% of patients reported finding TENS to be helpful and 55% were still using it daily.

Read the full article.

"The NIH Collaboratory was essential in helping the study team to design and execute FM-TIPS; we could not have done it without their continued consultation and support," Sluka said.

FM-TIPS is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Learn more about FM-TIPS.

March 24, 2026: Study Design Paper Published for Chat 4 Heart Health

Posted on by Damon Seils

Dr. Michael Ho and Dr. Sheana Bull, principal investigators for NudgeThe study design paper for Chat 4 Heart Health has been published online in Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The Chat 4 Heart Health trial is testing the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors, including physical activity and medication adherence. The study will provide evidence regarding the best population-based strategy for universal delivery to engage patients in self-management to improve the American Heart Association’s “Life’s Essential 8” measures for improving and maintaining cardiovascular health.

The study is being led by Mike Ho of Kaiser Permanente Colorado and Sheana Bull of the Colorado School of Public Health and is supported by a grant award from the National, Heart, Lung, and Blood Institute.

Read the full study design paper.

March 9, 2026: AIM-CP Nurse Care Management Program Shows Promise for Rural Patients With Chronic Pain

Posted on by Damon Seils

Headshots of Dr. Sebastian Tong and Dr. Kushang Patel
Dr. Sebastian Tong and Dr. Kushang Patel, principal investigators for AIM-CP

A pilot study of the AIM-CP intervention showed that an integrated nurse care management model is a feasible and effective way to deliver nonpharmacological chronic pain treatment to patients in rural communities. The findings will inform a full-scale randomized controlled trial to evaluate the intervention’s impact on a larger scale.

The results were published online ahead of print in Pain Medicine.

Rural residents experience higher rates of chronic pain but often lack access to evidence-based alternatives to opioids, such as cognitive behavioral therapy and exercise therapy. AIM-CP, an NIH Collaboratory Trial led by principal investigators Sebastian Tong and Kushang Patel of the University of Washington, will test a virtual nurse care management model that includes care coordination, cognitive behavioral therapy, and referral to a virtual exercise program.

The pilot study, conducted with 29 participants across healthcare systems in Washington and North Carolina, showed the intervention was feasible and had a high level of acceptability to patients. Participants experienced significant reductions in pain interference and improved satisfaction with their health. While adherence to nurse-led sessions was strong, the researchers observed low uptake for the exercise component, a challenge the team plans to address through enhanced training and support in the larger randomized trial.

AIM-CP is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant from the National Institute of Nursing Research. Learn more about AIM-CP.

February 24, 2026: Pragmatic Clinical Trials Offer Unique Opportunities to Study Implementation Processes and Outcomes

Posted on by Karen Staman

The interventions tested in pragmatic clinical trials are embedded into routine care practices, which offers opportunities to study implementation and sustainment outcomes.

In an article published online ahead of print in Implementation Science Communications, members of the NIH Pragmatic Trials Collaboratory’s Implementation Science Core share the results of a survey about the measurement of implementation outcomes in pragmatic trials.

Of the 32 NIH Collaboratory Trials, 29 completed the survey (91% response rate).

Main findings:

Across the trials, measurement was high for some constructs, including:

  • Reach (91%)
  • Adherence (76%)
  • Fidelity (93%)
  • Adaptations (69%)

However, evaluation for some constructs remains low:

  • Costs (31%)
  • Clinician adoption and representativeness (45%)
  • Anticipated sustainment (24%)
  • Actual sustainment (38%)

The authors suggest there is opportunity for growth in measuring some of these important implementation constructs.

“To benefit from the substantial investment into pragmatic clinical trials, we need to improve measurement of constructs that drive the implementation of evidence into routine care, including information about costs, sustainability, and sustainment,” the authors wrote.

Measurement of these constructs in future pragmatic trials could result in development of improved implementation strategies to increase the likelihood of effective implementation leading to equitable, sustainable, and scalable improvement in practice.

Read the full article.

For more information about implementation in pragmatic clinical trials, see the Living Textbook Chapter on Implementation.